PROJECT SUMMARY - Significance: Young women (16-24 years old) in sub-Saharan Africa are a vulnerable population in terms of HIV acquisition with ~7,000 new infections occurring per week. Oral daily pre-exposure prophylaxis (PrEP) is a highly effective means of HIV prevention when taken regularly. Early experience with the global rollout of PrEP in this population indicates enthusiasm for PrEP, but also barriers to adherence and program retention. Proposed intervention: PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, our overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health. Innovation: This study is the first, to our knowledge, to develop a peer-delivered kit for PrEP use, sexually transmitted infection (STI) testing, and contraception. The intervention leverages smart use of readily available technology (e.g., SMS, WhatsApp, Vimeo) to support use of the kit and peer-based empowerment. Approach: We will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya (Aim 1). We will use a client-centered, iterative approach, involving ~15 individual interviews and two focus group discussions (with ~5 women each) to optimally design the PrEP My Way kit (with instructional materials) and peer delivery system (including communication and kit delivery plans). We will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention (Aim 2). We will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic- based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Potential influencing and mediating socio-behavioral factors will be explored with questionnaires at baseline and 6 months. Investigators/environment: Our team has extensive relevant experience to ensure the success of this proposal, including PrEP adherence and behavioral science (PI: Dr. Haberer at Massachusetts General Hospital), sexual health service delivery (Dr. Bukusi at the Kenyan Medical Research Institute, Dr. Baeten at the University of Washington), and remote delivery and monitoring for PrEP and STIs (Dr. Siegler at Emory), as well as product design (ARK in Nairobi). Future directions: PrEP My Way is designed with limited infrastructure needs, thus creating potential for real world implementation at scale that can be tested in a future R01 grant.